European Medicines Agency (EMA)
The European Medicines Agency is the EU body that scientifically evaluates medicines and issues committee opinions, although the marketing authorisation itself is granted by the European Commission.
The EMA is a decentralised agency of the European Union, based in Amsterdam since its 2019 relocation from London. It does not itself authorise medicines. Its Committee for Medicinal Products for Human Use adopts a scientific opinion, which the European Commission then converts into a marketing authorisation valid across all member states. Assessment work is carried out by rapporteurs drawn from national agencies rather than by a single in-house review division.
The centralised procedure is compulsory for biotechnology-derived products, orphan medicines and products in a defined set of areas including diabetes, cancer, HIV, neurodegenerative and autoimmune disease, which captures essentially every incretin and growth hormone product. The clock runs 210 active days with stops for questions, and the outcome is published as a European public assessment report, an unusually detailed document that also exists for refused and withdrawn applications.
Reading both agencies is how the seams become visible. An assessment report often discusses subgroups, manufacturing concerns and rejected claims that a US label compresses into a sentence, and where the two agencies reach different conclusions on the same dossier the reasoning is usually there in the European report. Approval in one jurisdiction is not evidence of approval in the other and never implies it.
The habitual error is the phrase EMA-approved. The Commission approves and the agency advises. A related slip treats a European authorisation as covering the United Kingdom, which it has not done since Brexit, where the MHRA now authorises separately. National, mutual recognition and decentralised routes also exist, so a medicine authorised in one member state may never have been near the EMA.